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Feasibility of 1 Hour Clear Fluid Fasting Prior to Paediatric GA

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ClinicalTrials.gov Identifier: NCT03952260
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Ma Tai Jiun, University of Malaya

Brief Summary:

The study is aim to investigate the appropriate fasting time for clear fluid in paediatric patients who plan for elective minor surgery.

This is a randomize control trial, which patient will be selected randomly to fast for clear fluid for 1 hour or 2 hours.

It is important to determine the gastric residual volume for paediatric age group prior to elective minor surgery in order to determine whether the difference between 1 hour fasting and 2 hour fasting for clear fluid is significant.


Condition or disease Intervention/treatment Phase
Gastric Residual Volume Other: Fasting time for clear fluid prior to anaesthesia Not Applicable

Detailed Description:

This study is to evaluate the latest fasting protocol that is currently adopted and recommended by United Kingdom, France and Royal Children Hospital Melbourne.

The research question is should investigator change fasting protocol for paediatric patients prior to operation.

The anaesthesia service is being studied. Participants are patients who are 5-16 years old are planned for elective minor surgery in ent, eye, dental surgery, general surgery and orthopaedics.

This study will be done in UMMC. 2 groups of patients will be recruit which consists of 50 patients each. Each of the group will be instructed to fast for clear fluid for 1 hour or 2 hours prior to surgery. Prior to induction, the amount of abdominal contents was examined using ultrasound scan. In addition, patients anxiety level prior to and 1 hour post general anaesthesia will be assess. Also, parents of patients will complete a questionnaire after the surgery to assess parental satisfaction toward anaesthesia service.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Blinded against those who are doing ultrasound assessment of gastric residual volume prior to anaesthesia
Primary Purpose: Prevention
Official Title: A Randomised Control Trial Comparing 6-4-1 Fasting Protocol Against Classical 6-4-2 Fasting Guideline for Paediatric Patients
Estimated Study Start Date : May 15, 2019
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : February 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Fasting clear fluid for 1 hour prior to anaesthesia
Fasting clear fluid for 1 hour prior to anaesthesia
Other: Fasting time for clear fluid prior to anaesthesia

This study is to evaluate the latest fasting protocol that is currently adopted and recommended by United Kingdom, France and Royal Children Hospital Melbourne.

The research question is should we change our fasting protocol for paediatric patients prior to operation The anaesthesia service is being studied. Prior to induction, the amount of abdominal contents was examined using ultrasound scan. In addition, parents will complete a questionnaire after the surgery to assess anxiety level of patients before and after the surgery.


No Intervention: Fasting clear fluid for 2 hours prior to anaesthesia
Fasting clear fluid for 2 hours prior to anaesthesia



Primary Outcome Measures :
  1. Gastric residual volume by ultrasound after application of clear fluid fasting for 1 hour versus 2 hours prior to general anaesthesia [ Time Frame: Prior to induction of general anaesthesia ]

    We use ultrasound to evaluate gastric volume We scanning distal parts of the stomach-antrum in a semi-sitting or RLD position.

    A linear high-frequency (e.g. 5-12 MHz) transducer can be used in leaner or paediatric patients or to obtain detailed images of the gastric wall(4-6mm).

    Antral cross sectional area(CSA) can be measured by using two perpendicular diameters and the formula of the area of an ellipse: CSA=(AP×CC×π)/4 (AP=antero-posterior diameter and CC=craniocaudal diameter)

    GV (ml)=27.0+14.6×right-latCSA−1.28×age(Perlas and colleagues formula)

    Total gastric residual volume is then divide by body weight to get ml/kg, the lower the value the better the outcome.

    Referance standard is gastric residual volume acquired through nasogastric suction using nasogastric tube.

    Result of >1.5ml/kg show that patient posed risk of aspiration, result of >1ml/kg is significantly increase in this study



Secondary Outcome Measures :
  1. Anxiety level of patients by short version of(mYPAS)modified Yale Preoperative Anxiety Scale after application of clear fluid fasting for 1 hour versus 2 hours prior to paediatric general anaesthesia [ Time Frame: Prior to induction of general anaesthesia and 1 hour post anaesthesia ]

    Total score from 22.916(minimum score= least anxiety level/total relaxation) to 100 (maximum score= maximum anxiety level/ panic attack)

    Total score is obtained from 4 subscale as describe below:

    A. Activity (1-4) B. Vocalizations(1-6) C. Emotional expressivity(1-4) D. State of apparent arousal (1-4) Total score: Divide each item rating by the highest possible rating (i.e., 6 for the "vocalizations" item and 4 for all other items), add all of the produced values, divide by 4, and multiply by 100


  2. Parental satisfaction by questionnaires after application of clear fluid fasting for 1 hour versus 2 hours prior to paediatric general anaesthesia [ Time Frame: 2 hours to 24 hours post anaesthesia ]

    Total score from 20(minimum score= not satisfy) to 100 (maximum score= highly satisfy) Total score is obtained from 11 answer to the 11 questions

    each of the answer will be score as: Strongly Agree(5 )- Agree(4 )- Neither Agree nor Disagree(3)- Disagree(2) -Strongly Disagree(1) except answers for questionnaire number 3,6,8 will be score as: Strongly Agree(1 )- Agree(2 )- Neither Agree nor Disagree(3)- Disagree(4) -Strongly Disagree(5) Total score calculation: Divide each item rating by 5, add all of the produced values, divide by 11, and multiply by 100




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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 5-16 years old
  • elective open minor surgery in ent, eye, dental surgery, general surgery and orthopaedics

Exclusion Criteria:

  • Gastro‐oesophageal reflux (GORD)
  • renal failure
  • severe cerebral palsy
  • some enteropathies
  • oesophageal strictures
  • achalasia
  • diabetes mellitus with gastroparesis
  • surgical contra‐indications
  • Emergency cases
  • patients that were already intubated

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952260


Contacts
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Contact: Ma Tai Jiun, Dr +60198618098 taijiun86@gmail.com

Locations
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Malaysia
University Malaya Medical Centre Not yet recruiting
Kuala Lumpur, Malaysia, 50603
Contact: Tunku Kamarul Zaman bin Tunku Zainul Abidin, Prof. Dr.    +6037949 2000      
Sponsors and Collaborators
Ma Tai Jiun
Investigators
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Principal Investigator: Ma Tai Jiun, Dr University of Malaya
Study Chair: Ina Ismiarti binti Shariffuddin, Ass. Prof University of Malaya

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Responsible Party: Ma Tai Jiun, Principal investigator, University of Malaya
ClinicalTrials.gov Identifier: NCT03952260     History of Changes
Other Study ID Numbers: 2019211-7120
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The IPD will not be share because the IPD data is not particularly important in deciding the feasibility of 1 hour clear fluid fasting guideline.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ma Tai Jiun, University of Malaya:
Clear fluid fasting
residual gastric volume
paediatric anaesthesia

Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs